A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
Summary
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Timeline
- Start
- 2021-10-28
- Primary completion
- 2026-06-09
- Completion
- 2027-07-30
Outcome
Met primary endpoint
release “Positive high-level results from the DESTINY-Lung04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)” astrazeneca.com ↗
release “DESTINY-Lung04 is the first Phase III trial to demonstrate superior progression-free survival versus the global first-line standard of care” astrazeneca.com ↗
release “In the primary endpoint of PFS, Enhertu monotherapy significantly reduced the risk of disease progression or death by 37.0% versus pembrolizumab plus chemotherapy” astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Comparator | Cisplatin | Other / unclassified | — | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Comparator | Pemetrexed | Small molecule | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |